Back to resultsThe Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Primary Purpose
Metabolic Syndrome X
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Omega-3 fatty acids
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome X focused on measuring Fatty Acids, Omega-3
Eligibility Criteria
Inclusion Criteria: Adults with Metabolic Syndrome (meets 3 of the following 5) Abdominal obesity, waist circumference in men greater than 40 in. & in women greater than 35 in. Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L) Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure Fasting plasma glucose greater than 100 mg/dL Exclusion Criteria: Diabetes Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication) Angina or other chest pain that may indicate CHD Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) Known abnormal LFTS greater than 2X ULN Smoker, illicit drug use, or excessive alcohol use Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months Pregnancy or planning pregnancy during the study period Sensitivity or allergy to fish
Sites / Locations
- Northwest Lipid Research Clinic (University of Washington Affiliated)
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
1
Arm Description
Omega-3 fatty acid vs. placebo comparator
Outcomes
Primary Outcome Measures
Change in Carotid IMT
Secondary Outcome Measures
Lipid (apolipoproteins and lipid parameters)
hs-CRP & SAA
Glucose
Insulin
adiponectin
urine microalbumin/creatinine
Serum Fatty Acids
Full Information
NCT ID
NCT00350194
First Posted
July 6, 2006
Last Updated
February 29, 2012
Sponsor
University of Washington
Collaborators
Pfizer, National Institutes of Health (NIH), Northwest Lipid Research Clinic
1. Study Identification
Unique Protocol Identification Number
NCT00350194
Brief Title
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
Official Title
Pilot Study: The Effects of Omega-3 Fatty Acids on Metabolic Syndrome and Vascular Structure in Metabolic Syndrome as Assessed by Carotid IMT
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
June 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Pfizer, National Institutes of Health (NIH), Northwest Lipid Research Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the effects of omega-3 fatty acids in the form of fish oil supplementation (approximately 2 grams per day) on the carotid intima-media (CIMT)progression (primary objective) and 2)(Secondary objective) lipid markers such as LDL, apo-B, and LDL buoyancy, on inflammatory burden as measured by CRP, on oxidative stress as measured by urinary isoprostanes, urine microalbumin/creatinine, and serum adiponectin a fat derived hormone in subjects with metabolic syndrome.
Detailed Description
This translational pilot study will have a double-blind, placebo-controlled, parallel design. We will enroll one hundred subjects who meet at least 3 of the 5 criteria for metabolic syndrome as per NCEP guidelines/WHO guidelines and who do not have known cardiovascular disease or diabetes. They will receive either placebo or omega-3 fatty acids in the form of fish oil capsules for a two-year period. Assessment of, C-IMT, serum lipoprotein profile, LDL- buoyancy, adiponectin, CRP, SAA, apolipoprotein B and A-1, fasting glucose, fasting insulin levels, and plasma fatty acids will be measured at baseline, one year, and two years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
Keywords
Fatty Acids, Omega-3
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Omega-3 fatty acid vs. placebo comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 fatty acids
Other Intervention Name(s)
Fish Oil
Intervention Description
Total of 1.8 grams of EPA +DHA in the form of fish oil capsules (3/day)
Primary Outcome Measure Information:
Title
Change in Carotid IMT
Time Frame
1 year, 2 years
Secondary Outcome Measure Information:
Title
Lipid (apolipoproteins and lipid parameters)
Time Frame
1 year, 2 years
Title
hs-CRP & SAA
Time Frame
1 year, 2 years
Title
Glucose
Time Frame
1 year, 2 years
Title
Insulin
Time Frame
1 year, 2 years
Title
adiponectin
Time Frame
1 year, 2 years
Title
urine microalbumin/creatinine
Time Frame
1 year, 2 years
Title
Serum Fatty Acids
Time Frame
1 year, 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with Metabolic Syndrome (meets 3 of the following 5)
Abdominal obesity, waist circumference in men greater than 40 in. & in women greater than 35 in.
Serum triglycerides greater than or = 150 mg/dL (1.7 mmol/L)
Serum HDL cholesterol less than or = 40 mg/dL in men and less than 50 mg/dL in women
Blood pressure greater than or = 130/85 mmHg or drug treatment for elevated blood pressure
Fasting plasma glucose greater than 100 mg/dL
Exclusion Criteria:
Diabetes
Known or documented CHD (including ECG consistent with prior MI), CVA (including TIA), PVD (including symptoms of claudication)
Angina or other chest pain that may indicate CHD
Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable)
Known abnormal LFTS greater than 2X ULN
Smoker, illicit drug use, or excessive alcohol use
Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, Omega-3 fatty acid supplement, other investigational drugs within 30 days of study entry, high omega-3 fatty acid content in diet within past three months
Pregnancy or planning pregnancy during the study period
Sensitivity or allergy to fish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pathmaja Paramsothy, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Lipid Research Clinic (University of Washington Affiliated)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Omega-3 Fatty Acids on Metabolic Syndrome
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